Cleared Traditional

K080582 - MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA

K080582 is an FDA 510(k) clearance for MEDICATECH, manufactured by Medicatech USA. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K080582 · Medicatech USA · Radiology device
Download Printable Device Report (PDF)
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May 2008
Decision
73d
Days
Class 2
Risk

K080582 is an FDA 510(k) clearance for the MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Medicatech USA (Deer Field, US). The FDA issued a Cleared decision on May 15, 2008 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medicatech USA devices

FDA 510(k) Submission Details - K080582

510(k) Number K080582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2008
Decision Date May 15, 2008
Days to Decision 73 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 107d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KPR System, X-ray, Stationary

All 299
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K080582.
RADVISION ET DIAGNOSTIC X-RAY SYSTEM
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K080614 · Almana Medical Imaging · Jun 2008
CHRYSALIS
K080655 · Meta Imaging Solutions, LLC · May 2008
DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16
K080553 · Vieworks Co., Ltd. · Apr 2008
FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371
K073650 · Fujifilm Medical Systems U.S.A, Inc. · Feb 2008